Developer granted patent in Japan for masitinib use in progressive MS
AB Science plans to seek similar protection in other regions for drug's use in MS
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Developer AB Science was granted a patent in Japan covering its investigational oral therapy masitinib for progressive forms of multiple sclerosis.
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The new patent provides protection for this indication through February 2041.
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A clinical trial is now testing masitinib's ability to slow disability progression in people with progressive MS.Â
AB Science has received a patent in Japan covering the use of its investigational oral therapy masitinib for progressive forms of multiple sclerosis (MS).
The new patent — JP 7788154 — grants the France-based pharmaceutical company protection in the Asian nation through February 2041 on the use of masitinib for both primary progressive MS (PPMS) and nonactive secondary progressive MS (SPMS).
It also makes Japan the first country to formally grant patent protection specifically for this treatment approach in progressive forms of MS, according to a press release from AB Science. The company said it plans to seek similar protection in other regions.
Masitinib is already covered by worldwide patents for amyotrophic lateral sclerosis (ALS) through 2037, and AB Science also holds patents for its use in other conditions, such as Alzheimer’s disease, sickle cell disease, and certain cancers and inflammatory disorders.
In MS, the immune system mistakenly attacks healthy parts of the brain and spinal cord, causing ongoing inflammation that damages nerve cells.
Progressive forms of MS are characterized by a steady worsening of disability and are thought to be driven in part by chronic inflammation involving the innate immune system, including mast cells and microglia. This differs from relapsing forms of MS, which are largely driven by immune responses involving B-cells and T-cells.
Drug’s approach is different from most available therapies
Masitinib, previously known as AB1010, is a small molecule designed to inhibit enzymes involved in the activation and survival of mast cells and microglia. It blocks the activity of tyrosine kinases, which play a key role in mast cell and microglial activation and growth. By reducing their numbers and activity, the therapy aims to reduce inflammation in the brain and spinal cord and slow disease progression.
This approach differs from most currently available MS treatments, which mainly target inflammatory processes outside the brain and spinal cord that drive relapses and active inflammation. These therapies are effective in relapsing forms of the disease but have limited impact in progressive forms.
According to AB Science, masitinib’s development in progressive forms of MS is supported by results from a now-completed Phase 2b/3 clinical trial and an ongoing confirmatory Phase 3 study.
That first clinical trial, called AB07002 (NCT01433497), enrolled 656 adults with PPMS or nonactive SPMS who were randomly assigned to receive masitinib at daily doses of 4.5 mg/kg or 6 mg/kg, or a placebo, for about two years.
The final results showed that the lower dose significantly slowed disability progression compared with the placebo, as measured by changes in the Expanded Disability Status Scale (EDSS), meeting the study’s main goal.
Participants on this dose also had a 42% lower risk of first disability progression and a 37% lower risk of three-month confirmed disability progression. Also, the risk of reaching an EDSS score of 7 — indicating a level of disability severe enough to require a wheelchair — was significantly lower with this dose.
MAXIMS trial now testing masitinib in adults with PPMS, SPPMS
Based on those findings, the U.S. Food and Drug Administration cleared AB Science in 2023 to begin the MAXIMS Phase 3 trial (NCT05441488), also known as AB20009. The ongoing study is evaluating masitinib at a daily dose of 4.5 mg/kg versus a placebo in about 800 adults with PPMS or nonactive SPMS.
The study is expected to conclude in 2028, and its main goal is to confirm whether masitinib can delay confirmed disability progression over nearly two years of treatment. No data from the trial have yet been reported.
According to AB Science, masitinib has been studied across multiple indications in more than 4,300 patients, including 1,200 patients who have been treated for more than a year, and has a well-established safety profile. Unlike available therapies that target B-cells, the therapy does not increase the risk of infection.
The developer said it expects the patent approval granted in Japan to be only the first for this indication.
“AB Science is optimistic in its chance to receive the protection of the use of masitinib in progressive MS worldwide,” the company stated.
